Assessing airway collapse predictors in obstructive sleep apnea patients
The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea
This study is testing if a quick and easy mouth measurement can help predict which obstructive sleep apnea patients will benefit from airway surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Inspire Medical Systems, Inc. Industry-sponsored |
| Locations | 10 sites (Scottsdale, Arizona and 9 other locations) |
| Trial ID | NCT05428839 on ClinicalTrials.gov |
What this trial studies
This exploratory multicenter study involves up to 300 subjects diagnosed with obstructive sleep apnea who are being evaluated for airway surgery. Participants will undergo standard evaluations for airway surgery, along with a simple, non-invasive measurement of the pharyngeal width inside their mouths, which takes about 2-3 minutes. The goal is to determine if this measurement can predict the absence of complete concentric collapse at the soft palate, potentially improving surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with obstructive sleep apnea who are being evaluated for Inspire Upper Airway Stimulation surgery.
Not a fit: Patients who are unable to lie supine for the measurement or deemed unfit by the investigator may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of surgical evaluations for patients with obstructive sleep apnea.
How similar studies have performed: While this approach is exploratory, similar studies have shown promise in improving diagnostic accuracy for obstructive sleep apnea treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient meets the indications for the Inspire Upper Airway Stimulation * Patient is being evaluated by drug-induced sleep endoscopy as standard-of-care diagnostic for OSA surgery. Exclusion Criteria: * Patient is unable to lie supine for 2-3 minutes in order to undergo airway measurement * Any other reason the investigator deems that the patient is unfit for participation in the study.
Where this trial is running
Scottsdale, Arizona and 9 other locations
- Valley ENT — Scottsdale, Arizona, United States (Recruiting)
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
- Mason City Clinic — Mason City, Iowa, United States (Recruiting)
- Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States (Recruiting)
- ENT Specialty Care of MN — Saint Louis Park, Minnesota, United States (Recruiting)
- Ohio State University — Columbus, Ohio, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Anna N Bader
- Email: annabader@inspiresleep.com
- Phone: 763-290-1174
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.